Reynoso G
Cancer. 1978 Sep;42(3 Suppl):1406-11. doi: 10.1002/1097-0142(197809)42:3+<1406::aid-cncr2820420804>3.0.co;2-0.
We evaluated the analytical reliability of the carcinoembryonic antigen (CEA) method of Hansen. Our experience is based on performing over 23,000 CEA assays in more than 10,000 clinical samples. The sensitivity of the assay is 0.5 ng/ml. The precision must be defined as a function of concentration. In the range 2.6 to 12 ng/ml the coefficient of variation is 4.96 to 7.39%. Long-range studies of the reproducibility of the standard curve, over a period of several years and including 435 standard curves, have shown an overall mean B/Bo of 31.45% which is close to the theoretical optimal of 33%. The long-term 90 and 50% intercepts are 0.55 +/- 0.15 and 7.11 +/- 1.0, respectively. Interlaboratory surveys show good agreement between the means of the survey group and the target values but rather large individual discrepancies. The CEA method studied here is sensitive and reproducible in intralaboratory studies but less so in interlaboratory comparisons. The reagents have performed uniformly and close to specifications over an extended period of time.
我们评估了汉森癌胚抗原（CEA）检测方法的分析可靠性。我们的经验基于对超过10000份临床样本进行了23000多次CEA检测。该检测方法的灵敏度为0.5 ng/ml。精密度必须定义为浓度的函数。在2.6至12 ng/ml范围内，变异系数为4.96%至7.39%。在数年时间里对标准曲线重现性进行的长期研究，包括435条标准曲线，显示总体平均B/Bo为31.45%，接近理论最优值33%。长期90%和50%截距分别为0.55±0.15和7.11±1.0。实验室间调查显示，调查小组的均值与目标值之间一致性良好，但个体差异较大。此处研究的CEA检测方法在实验室内部研究中灵敏且可重复，但在实验室间比较中则不然。这些试剂在较长一段时间内性能一致且接近规格要求。
